Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill

Launched by DENVER HEALTH AND HOSPITAL AUTHORITY · Dec 9, 2013

Keywords

ClinConnect Summary

The inflammatory response associated with surgical critical illness rapidly induces a functional iron deficiency, characterized by hypoferremia, decreased transferrin saturation (TSAT), hyperferritinemia, and iron-deficient erythropoiesis (IDE). This functional iron deficiency both contributes to intensive care unit (ICU) anemia and increases the packed red blood cell (pRBCs) transfusion requirement.

The goals of iron supplementation of critically ill surgical patients are to reverse the serum iron debt, eliminate IDE, improve anemia, and decrease pRBCs transfusions. Issues surrounding iro...

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Eligibility criteria

• Inclusion Criteria:
• • Anemia (hemoglobin \< 12 g/dL).
• * Functional iron deficiency:
• • 1. Serum iron concentration \< 40 ug/dL
• • 2. TSAT \< 25%
• • 3. Serum ferritin concentration \> 28 ng/mL
• • \< 72 hours from ICU admission.
• • Expected ICU length of stay ≥ 7 days.
• Exclusion Criteria:
• • Age \< 18 years.
• • Active bleeding requiring pRBCs transfusion
• • Iron overload (serum ferritin concentration ≥ 1,500 ng/mL). The serum ferritin concentration is an acute phase reactant that is increased during critical illness regardless of total body iron \[3\]. Substantial levels of hyperferritinemia (serum ferrinin concentration \> 1,000 ng/dL) were observed in both NCT00450177 and NCT01180894 without increased risk of infection and despite both low TSAT and IDE. For these reasons, we believe that relative hyperferritinemia (serum ferritin concentration 500 - 1,500 ng/dL) is neither harmful nor indicative of bone marrow iron availability.
• • Infection, defined using US Centers for Disease Control and Prevention (CDC) guidelines, with the exception of ventilator-associated pneumonia (VAP), which is defined as clinical suspicion for pneumonia along with a lower respiratory tract culture with ≥ 105 colony forming units per mL.
• • Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis).
• • Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease).
• • Macrocytic anemia (admission mean corpuscular volume ≥ 100 fL).
• • Current or recent (within 30 days) use of immunosuppressive agents.
• • Use of any recombinant human erythropoietin formulation within the previous 30 days.
• • Pregnancy or lactation.
• • Legal arrest or incarceration.
• • Prohibition of pRBCs transfusion.
• • Stay of ≥ 48 hours duration in the ICU of a transferring hospital.
• • History of intolerance or hypersensitivity to iron.
• • Moribund state in which death was imminent.

Trial Officials